Your mission

The main purpose of the Manufacturing Technician is to perform manufacturing and improvement activities in accordance with Good Manufacturing Practice to support the manufacture of Advanced Therapy Medicinal Products [ATMP].

Job Description

Major Activities

Responsible for performing manufacturing and improvement activities in accordance with Good Manufacturing Practice to manufacture ATMP.
Responsible for identifying, reporting and supporting health and safety issues and investigations, and responsible for identifying potential health and safety improvements.
Responsible for maintaining own work and work area in an inspection-ready state at all times.
Responsible for driving personal development, seeking opportunities to grow and expand additional capabilities.
Responsible for communicating professionally, accurately and in a timely manner with team members and other stakeholders.
Responsible for identifying, collaborating and delivering continuous improvements within the manufacturing area to improve safety, quality and flow.
Responsible for identifying, reporting and supporting quality issues and investigations.
Responsible for ensuring that individual and co-worker work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
Responsible for ensuring that the necessary training is undertaken in a timely and GMP compliant manner before the task is undertaken.
Responsible for ensuring that any GMP documentation assigned is closed in a timely manner, right-first time and in compliance with MeiraGTx procedures.
Responsible for ensuring the facility and materials are sanitised, monitored and controlled adequately to prevent contamination or cross-contamination.
Responsible for movement and preparation of materials required for bioprocessing and support activities inclusive of their management within the Enterprise Resource Planning system.
Responsible for ensuring materials used within manufacturing are correct, clean, appropriate and in place ready for manufacture to the agreed schedule.

Key Performance Indicators

Safe working of self and with others.
Compliance with GMP requirements including Data Integrity.
Excellent cleanroom behaviours.
Timely closure of GMP commitments.
High standards of professional conduct including timeliness, teamwork, respect for others, and commitment.
All training completed prior to undertaking a task, with no overdue training.

Key Job Competencies

Good Documentation Practice - Operates to appropriate manufacturing practices and procedures to produce and complete documentation of the highest standard.
Cleanroom behaviours – Operates to a high standard of hygiene and technique within cleanrooms to maintain the required level of cleanliness for ATMP manufacturing.
Motivation - demonstrates persistence and overcomes obstacles; strives for excellence and demonstrates consistent pride in own work.
Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for their own actions; follows through on commitments.
Quality Improvement - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job Responsibilities

Responsible for GxP compliance within designated processing areas.
Accountable for safety of self and team within designated processing areas

Experience / Professional Background

Fluent English language (written and oral).
Competency and familiarity with basic IT systems (e.g. Microsoft Office, etc.)
Previous experience in a GMP manufacturing environment (preferred not mandatory).

Why us?